The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas

The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.

The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.

Inclusion Criteria:

• Age 12-20 years with type 1 diabetes for at least one year.
• Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.
• Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion).

Exclusion Criteria:

• Unable to provide informed assent
• Unable to comply with study procedures.
• Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
• Total daily dose (TDD) of insulin that is > 2 units/kg.
• Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
• Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is < 50 mg/dl)
• End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
• History of prolonged QT or arrhythmia
• History of congenital heart disease or current known cardiac disease
• Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study.
• Seizure disorder or history of hypoglycemic seizures or coma in the last five years
• Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
• Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference.
• Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications.
• History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
• Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study.
• History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight
• History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
• Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.